Diagnostic and Prognostic Value of Angiography-derived IMR (CHART-MiCro)

Diagnostic Value of Angiography-derived Index of Microvascular Resistance in Coronary Artery Disease Patients and Its Prognostic Implication After Percutaneous Coronary Intervention

The importance of the microvasculature in determining clinical outcomes has been highlighted in patients with coronary artery disease (CAD). For patients with stable CAD, despite the success of percutaneous coronary intervention (PCI) in relieving a stenosis in the epicardial coronary artery, microvascular dysfunction may preclude sufficient coronary flow and myocardial perfusion, possibly leading to worse clinical outcome. With the technical development of computational fluid dynamics, angiographic derivation of index of Index of Microcirculatory Resistance (IMR) without pressure wire, hyperemic agents, or theromdilution method is available as a potential alternative for pressure wire-derived IMR. In this regard, the current study will evaluate diagnostic implication of angiography-derived IMR and its prognostic implication after PCI in patients with stable CAD.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Ischemia; Coronary Microvascular Dysfunction
• Intervention / Treatment: Device: Angiography-drived Index of Microcirculatory Resistance

Detailed Description

The importance of the microvasculature in determining clinical outcomes has been highlighted in patients with coronary artery disease (CAD). For patients with stable CAD, despite the success of percutaneous coronary intervention (PCI) in relieving a stenosis in the epicardial coronary artery, microvascular dysfunction may preclude sufficient coronary flow and myocardial perfusion, possibly leading to worse clinical outcome. With the technical development of computational fluid dynamics, angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method is available as a potential alternative for pressure wire-derived IMR. In this regard, the current study will evaluate diagnostic implication of angiography-derived IMR and its prognostic implication after PCI in patients with stable CAD.

This study cohorts consist with 3 separate cohort: first, internal diagnostic accuracy cohort, which will evaluate correlation between angiography-derived IMR and hyperemic microvascular resistance calculated using Cadmium-Zinc-Telluride Single-Photon Emission Computed Tomography (CZT-SPECT)-derived myocardial blood flow and invasively measured pressure data. For this, 53 consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery will be evaluated. Second: external diagnostic cohort, in which diagnostic accuracy of angiography-derived IMR will be assessed in patients with ischemia and no obstructive coronary artery disease (INOCA) and normal controls, whose results were previously published (J Nucl Cardiol. 2020 Sep 30. doi: 10.1007/s12350-020-02252-8.) Among this cohort, 45 patients with no obstructive CAD and normal CZT-SPECT perfusion imaging will be regarded as normal controls, in 35 INOCA patients, vessels with normal corresponding perfusion territory will be regarded as internal control. Third, prognosis cohort, in which 138 consecutive CAD patients received PCI with available angiograms and who were suitable for angiographic fractional flow reserve and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death or congestive heart failure at 2 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission and angina pectoris admission at 2 years from index procedure.

• Study Type: Observational
• Enrollment (Anticipated): 271

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200091
    • Shanghai Tenth People's Hospital
    • Contact: Wenliang Che, MD, PhD
    • Principal Investigator: Wenliang Che, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnostic Accuracy Cohort, 53 stable CAD patients who underwent CZT-SPECT MBF and invasive pressure measurements in LAD within 7 days.

Diagnostic Accuracy Cohort, 35 INOCA patients confirmed by CZT-SPECT and coronary angiography and 45 normal controls Prognosis Cohort 138 stable patients received PCI with available angiograms and who were suitable for angiographic FFR and IMR measurement and have 28 months follow-up data.

Description

Inclusion Criteria:

• CAD patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery (Cohort 1)
• INOCA patients and normal controls confirmed by CZT-SPECT and angiography (Cohort 2)
• Stable CAD patients received PCI (Cohort 3)
• analyzable angiograms at the index procedure

Exclusion Criteria:

• Previous coronary artery bypass grafting
• Chronic total occlusion patients
• limited image quality of coronary angiography
• Insufficient angiographic project for TIMI frame count
• Severe tortuosity of target vessel
• No optimal projection for reconstruction

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Internal Diagnostic Accuracy Cohort; Consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery. In these patients, correlation between angiography-derived IMR and hyperemic microvascular resistance will be assessed.	Device: Angiography-drived Index of Microcirculatory Resistance; From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation. Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}). Hyperemic Pa will be estimated from resting Pa according to prespecified equation.; Other Names: Angio-IMR; CaIMR
External Diagnostic Accuracy Cohort; Patients are subgroup of previously published study (J Nucl Cardiol. 2020 Sep 30. doi: 10.1007/s12350-020-02252-8.), INOCA patients and normal controls confirmed by CZT-SPECT and angiography will be included for the assessment of angiography-derived IMR in diagnosing microvascular dysfunction.	Device: Angiography-drived Index of Microcirculatory Resistance; From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation. Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}). Hyperemic Pa will be estimated from resting Pa according to prespecified equation.; Other Names: Angio-IMR; CaIMR
Prognosis Cohort; Prognosis cohort, in which angiography-derived IMR will be measured in the target vessel after successful revascularization. Those patients have follow-up data after 2 years from index procedure.	Device: Angiography-drived Index of Microcirculatory Resistance; From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation. Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}). Hyperemic Pa will be estimated from resting Pa according to prespecified equation.; Other Names: Angio-IMR; CaIMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Correlation between angiography-derived IMR and HMR	at the index procedure
Major adverse cardiac events	Major adverse cardiac events (MACE), including cardiac death and readmission due to heart failure.	at 28 months from index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite of cardiac death, readmission due to heart failure and angina	A composite of cardiac death, readmission due to heart failure and angina	at 28 months from index procedure
A composite of cardiac death, readmission due to heart failure, spontaneous MI, target vessel revascularization and angina	A composite of cardiac death, readmission due to heart failure, spontaneous MI, target vessel revascularization and angina.	at 28 months from index procedure
Cardiac death	Cardiac death	at 28 months from index procedure
Readmission due to heart failure	Readmission due to heart failure	at 28 months from index procedure
Spontaneous MI	Spontaneous MI	at 28 months from index procedure
Target vessel revascularization	Target vessel revascularization	at 28 months from index procedure
Readmission due to angina	Readmission due to angina	at 28 months from index procedure

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• De Maria GL, Scarsini R, Shanmuganathan M, Kotronias RA, Terentes-Printzios D, Borlotti A, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda R, Ferreira VM; Oxford Acute Myocardial Infarction (OXAMI) Study Investigators; Channon KM, Garcia-Garcia HM, Banning AP. Angiography-derived index of microcirculatory resistance as a novel, pressure-wire-free tool to assess coronary microcirculation in ST elevation myocardial infarction. Int J Cardiovasc Imaging. 2020 Aug;36(8):1395-1406. doi: 10.1007/s10554-020-01831-7. Epub 2020 May 14.
• Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020.
• Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 28, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: ZS-20210328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No